A clinical trial to study the efficacy of probiotic Lactobacillus brevis lozenges in patients with chronic periodontitis

A randomized, double blind, placebo controlled study of efficacy of Lactobacillus CD2 lozenges in patients with chronic periodontitis

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000006

Enrollment

150

Registered

2009-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lactobacillus CD2 lozenges: 6 lozenges per day for 8 weeks Control Intervention1: Placebo: 6 lozenges per day for 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1.Patients between 20-50 yrs of age groups. 2.Patients with chronic periodontitis with or without accompanying systemic conditions. 3.The patient should have at least 20 fully erupted teeth. 4.Patient agreeing to strictly follow study instructions and doctor?s advice for sucking the lozenges. 5.Patients ready to give written informed consent for participating in the trial. 6.Patients agreeing to comply with the study protocol and instructions.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1.Pregnant women and lactating mothers. 2.Has a debilitating systemic disease or disease that affects the periodontium. 3.Needs prophylactic antibodies. 4.Patients treated with antibiotic within 30 days prior to beginning of the study. 5.Is already a part of any other clinical trial or has taken any other investigational drug in the last 30 days. 6.Patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis. 7.Patients not willing to participate in the trial. 8.Patients with psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation. 6.Improvement in clinical photograph at the time of recruitment and at the end of the study. 7.Reduction of clinically detectable plaque to a level compatible with periodontal health. Timepoint: 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation. 7.Reduction of clinically detectable plaque to a level compatible with periodontal health. Timepoint- At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks) 6.Improvement in clinical photograph at the time of recruitment and at the end of the study Timepoint- Baseline and after 8 weeks (at end of the study)	—

Measure

Time frame

1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation. 6.Improvement in clinical photograph at the time of recruitment and at the end of the study. 7.Reduction of clinically detectable plaque to a level compatible with periodontal health. Timepoint: 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation. 7.Reduction of clinically detectable plaque to a level compatible with periodontal health. Timepoint- At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks) 6.Improvement in clinical photograph at the time of recruitment and at the end of the study Timepoint- Baseline and after 8 weeks (at end of the study)

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Secondary

Measure	Time frame
1.Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-&#945;, IFN-&#947;) in saliva and crevicular fluid samples 2.Comparison of Quality of life (QoL) in test and control group Timepoint: 1. Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-&#945;, IFN-&#947;) in saliva and crevicular fluid samples Timepoint- At baseline, and end of the study (after 8 weeks) 2.Comparison of Quality of life (QoL) in test and control group Timepoint-At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks)	—

Measure

Time frame

1.Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-&#945;, IFN-&#947;) in saliva and crevicular fluid samples 2.Comparison of Quality of life (QoL) in test and control group Timepoint: 1. Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-&#945;, IFN-&#947;) in saliva and crevicular fluid samples Timepoint- At baseline, and end of the study (after 8 weeks) 2.Comparison of Quality of life (QoL) in test and control group Timepoint-At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks)

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Countries

India

Contacts

Public ContactDr. Ajoy Roychoudhury

AIIMS

ajoyroy@hotmail.com9891007749, 011-26589303

Outcome results